Omega-3 Fatty Acids With PD-1 Inhibitors in Advanced Esophageal Cancer

NCT07272382 · tracked via the Priya Life Science China tracker

Sponsor

Fudan University

Phase

Not applicable

Started

2025-06-05

Last updated

2025-12-09

Condition(s) studied

Esophageal Neoplasms

Investigational drug(s) / intervention(s)

PD-1 + Omega-3 Fatty Acids (EPA/DHA)PD-1 + Placebo (Oral Drops)

PD-1 + Omega-3 Fatty Acids (EPA/DHA): Intervention: Omega-3 (EPA 2.5 g + DHA 1.25 g/day) oral drops × 6 months; with PD-1; blinded; adherence via check-ins/bottle counts/plasma EPA/DHA.

PD-1 + Placebo (Oral Drops): Comparator: Matching placebo oral drops × 6 months; with PD-1; blinded; adherence via check-ins/bottle counts.

Study summary

This is a randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate whether adding omega-3 fatty acids improves outcomes in adult patients with recurrent or metastatic esophageal cancer receiving PD-1 inhibitor therapy.

The main questions are:

Compared with placebo, does omega-3 (EPA+DHA) increase the longitudinal change in skeletal muscle index (ΔSMI) over 6 months? Does it improve clinical outcomes and favorably modulate immune and metabolic biomarkers as well as patient-reported outcomes ?

Participants will be randomized 1:1 to:

Intervention: Standard PD-1 therapy plus oral omega-3 (EPA 2.5 g + DHA 1.25 g per day) for 6 months.

Control: Standard PD-1 therapy plus matching placebo for 6 months. Participants will attend study visits at baseline, 3 months, and 6 months (then every 3 months up to 2 years), undergo body composition and functional assessments, blood sampling, and questionnaires, and have treatment adherence assessed per protocol. Pre-specified exploratory biomarker analyses will be conducted to support mechanism research.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria： Age ≥18 years; ECOG 0-2. Histologically confirmed recurrent/metastatic esophageal cancer (AJCC 8th; de novo stage IV or relapse after prior therapy). PD-1 inhibitor naïve, or prior PD-1 stopped \>3 months with subsequent progression (not primary PD-1 resistance). Adequate organ function per protocol (hematologic, hepatic, renal). Women of childbearing potential: negative pregnancy test and agree to effective contraception. Signed informed consent. Exclusion Criteria： PD-1 inhibitor resistance or refractory disease to prior PD-1. Esophageal fistula present or strongly suspected. Active autoimmune disease or immunodeficiency requiring systemic therapy (protocol-defined exceptions allowed, e.g., treated hypothyroidism; controlled type 1 diabetes). Systemic corticosteroids or other immunosuppressants requiring ongoing use (physiologic or topical steroids allowed). Interstitial lung disease/pneumonitis history or active pneumonitis on screening CT. Uncontrolled cardiovascular disease (e.g., NYHA ≥ II heart failure, unstable angina, recent MI, significant uncontrolled arrhythmias). Serious active infection, including active TB; uncontrolled viral hepatitis (active HBV/HCV per protocol). Pregnant or breastfeeding. Recent major surgery (per protocol window) or high bleeding risk/therapeutic anticoagulation not suitable for omega-3 use. Other conditions that, in investigator's judgment, preclude protocol compliance or safety.

Primary outcome measure(s)

Change in Skeletal Muscle Index (ΔSMI) From Baseline to 6 Months — From randomization to Month 6 (±4 weeks)

Trial sites (1)

Facility	City	Region	Status
Fudan University Shanghai Cancer Center	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07272382 on ClinicalTrials.gov ↗ ← All trials in China